ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of April 23, 2008 No. 380

About approval of the Technical regulation "Requirements to Safety of the Medicines and Biological Medicines Used in Veterinary Science"

For the purpose of implementation of the Law of the Republic of Kazakhstan of November 9, 2004 "About technical regulation" the Government of the Republic of Kazakhstan DECIDES:

1. Approve the enclosed Technical regulation "Requirements to Safety of the Medicines and Biological Medicines Used in Veterinary Science".

2. This resolution becomes effective after six months from the date of the first official publication.

Approved by the order of the Government of the Republic of Kazakhstan of April 23, 2008, No. 380

Technical regulation "Requirements to Safety of the Medicines and Biological Medicines Used in Veterinary Science"

1. Scope

1. This technical regulation "Requirements to Safety of the Medicines and Biological Medicines Used in Veterinary Science" (further - the Technical regulation) is developed according to the Law of the Republic of Kazakhstan of November 9, 2004 "About technical regulation".

2. This Technical regulation extends to all (imported) medicines and biological medicines used in veterinary science with codes on the qualifier of the Commodity nomenclature of foreign economic activity of the Republic of Kazakhstan made (made) and imported (further - the Commodity Nomenclature of Foreign Economic Activity) are specified in appendix 1 to this technical regulation.

Provisions of the Technical regulation extend to producers and sellers of the medicines and biological medicines used in veterinary science irrespective of their form of business.

3. The medicines and biological medicines used in veterinary science are allowed to production and application only after their state registration.

Drug circulation and the biological medicines used in veterinary science including their production, import (import), transportation, realization, application (use), destruction is subject to obligatory veterinary supervision.

4. This Technical regulation does not extend to prototypes of the medicines and biological medicines used in veterinary science, imported for carrying out state registration and also to the medicines made of genetically modified vegetable or other raw materials.

2. Terms and determinations

5. In this Technical regulation the following terms are used:

biological products - medicines which are intended for treatment, specific prevention of infectious, parasitic diseases and allergic conditions and also which receive by cultivation of strains of microorganisms and cages eukaryote, extractions of substances from biological tissues of animals and plants (allergens), implementations of technology recombinant дезоксирибо nucleic acid, gibridomny technology, reproduction of living agents in embryos or animals. Allergens, antigens, vaccines (anatoxins), immunomodulators of bacterial origin and received on the basis of bodies and fabrics, the medicines received from blood and plasma, serums, immunoglobulins, probiotics of interferona concern to them;

primary package - the packaging which is in direct contact with medicine for animals;

homeopathic medicines - one or multicomponent medicines containing the midget doses of substances of plant, animal, mineral origin made or made on special technology, applied by homeopathic rules in case of nonconventional methods of treatment;

диагностикум the means of biological or synthetic origin intended for diagnosis of diseases or physiological condition of animals, and also for indication and identification of microorganisms, products of their life activity and other biological objects;

medicine - medicine in certain dosage form;

балк - medicine product - the dosed medicine which passed all stages of engineering procedure of production of medicine except final packaging;

safety of medicines, biological medicines of production processes and operation - lack of the unacceptable risk connected with possibility of harming of life animals, health of the person and the environment;

secondary package - packaging in which the primary package is located;

medicines - the means containing pharmacological the active agents intended for prevention, diagnostics and treatment of diseases, and also change of condition and functions of organism: medicinal substance, medicinal substance, medicinal raw materials of natural origin, medicinal ангро - balkprodukta, medicines, immunobiological medicines. Including deratization, antiparasitic, the repellents, disinfecting and other veterinary means used for the purpose of diagnostics, prevention, treatment of diseases;

destruction of medicines and biological preparatovvozdeystviye on medicines, unsuitable to application and (or) further conversion, use excluding them and access to them for the person and animals;

drug circulation, biological the preparatovdeyatelnost performed in the course of finishing safe, effective and high-quality medicines, biological medicines from developer and (or) the producer to the consumer;

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info